Epidemiology of Diabetes Interventions and Complications (EDIC)

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ClinicalTrials.gov Identifier: NCT00360893

Recruitment Status :
Active, not recruiting

First Posted : August 7, 2006

Last Update Posted : November 20, 2017

Sponsor:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Information provided by (Responsible Party):

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

OBJECTIVE— The Diabetes Control and Complications Trial (DCCT) demonstrated the powerful impact of glycemic control on the early manifestations of microvascular complications.

Contemporary prospective data on the evolution of macrovascular and late micro vascular complications of type 1 diabetes are limited. The Epidemiology of Diabetes Interventions and Complications (EDIC) study is a multicenter, longitudinal, observational study designed to use the well-characterized DCCT cohort of 1,400 patients to determine the long-term effects of prior separation of glycemic levels on micro- and macrovascular outcomes. EDIC is in its 13th year of followup. The study is expecting to last until 2016.

RESEARCH DESIGN AND METHODS— Using a standardized annual history and physical examination, 28 EDIC clinical centers that were DCCT clinics will follow the EDIC cohort for 10 years. Annual evaluation also includes resting electro c a rdiogram, Doppler ultrasound measurements of ankle/arm blood pressure, and screening for nephropathy. At regular intervals, a timed 4-h urine is collected, lipid pro files are obtained, and stereoscopic fundus photographs are taken. In addition, dual B-mode Doppler ultrasound scans of the common and internal carotid arteries will be perf o rmed at years 1 and 6 and at study end.

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Ages Eligible for Study:

19 Years to 45 Years (Adult)

Sexes Eligible for Study:

All

Sampling Method:

Non-Probability Sample

Study Population

Patients enrolled in the DCCT

Criteria

Inclusion Criteria:

A participant in the Diabetes Control and Complications Trial (DCCT)(N01-DK-6-2204-A).